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SELLAS Announces Positive Topline Data in Lymphoma Cohort from SLS009 Phase 1 Dose-Escalation Trial, Supporting Advancement to Phase 2 Clinical Study; Primary and Secondary Endpoints Met
- 52 Relapsed and Refractory Lymphoma Patients Enrolled: 96% Alive at Last Assessment Indicating Favorable Survival Benefit - - Responses Observed Across Dose
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- 52 Relapsed and Refractory Lymphoma Patients Enrolled: 96% Alive at Last Assessment Indicating Favorable Survival Benefit - - Responses Observed Across Dose Levels with a 14.7% Clinical Response Rate Overall, 35.3% Overall Disease Control Rate, and 36.4% Clinical Response Rate in PTCL Patients - - Decrease in MCL1 and/or MYC Biomarkers Observed in 100% of Patients in a Dose-Dependent Manner in Once Per Week Administration Regimen - - Recommended Phase 2 Dose for Lymphoma Patients Established at 100 mg Once Per Week- - No Off-Target Safety Issues at any Dose Level – NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced positive topline data for the patient group with relapsed/refractory (r/r) lymphomas from the Phase 1 dose-escalation trial of its CDK9 inhibitor, SLS009 (GFH009). All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved. The recommended Phase 2 Dose (RP2D) for lymphoma patients has been established at the highest dose level evaluated of 100 mg, administered as a once-weekly infusion. The maximum tolerated dose (MTD) was not reached. A dose-limiting toxicity occurred in one out of five patients treated at the 100 mg dose level. No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study. “We are excited to share strong topline data from the Phase 1 trial of SLS009 in lymphoma patients, building upon the promising results in the cohort of patients with acute myeloid leukemia (AML) which we reported earlier this year,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The data demonstrate meaningful anti-tumor activity and clinical responses as a monotherapy. Based on its favorable therapeutic profile, SLS009 continues to emerge as a potential treatment for patients with hematologic malignancies who have exhausted available treatment options. Our partner, GenFleet Therapeutics, plans to advance GFH009 (SLS009) into Phase 2 clinical studies in China for patients with peripheral T-cell lymphoma (PTCL) la...